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“By approving opioids indicated for the treatment of chronic pain without substantial evidence of their efficacy for this indication, the FDA has helped to facilitate the launch of the U.S. opioid epidemic,” PMRS said. Read More
Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Read More
Sen. Bernie Sanders (I-Vt.) and Rep. Ro Khanna (D-Calif.) plan to introduce a bill that would limit U.S. prescription drug prices to the median prices in five other nations. Read More
A lawsuit filed in the Southern District of West Virginia alleges marketing tactics by drugmakers and distributors caused children to be born addicted to opioids. Read More
Mallinckrodt’s proposed patient access program for its Acthar gel injection could open the door for fraud and abuse under the Anti-Kickback statute, the HHS Office of the Inspector General (OIG) warned in response to the drugmaker’s inquiries. Read More
For years, sponsors, researchers and other experts have urged the FDA to consider metastasis-free survival a primary endpoint for trials aimed at nmCRPC. Read More